Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000379910
Ethics application status
Approved
Date submitted
26/02/2020
Date registered
19/03/2020
Date last updated
9/02/2022
Date data sharing statement initially provided
19/03/2020
Date results provided
19/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of providing online information to parents of children with communication difficulties.
Scientific title
Clinical effectiveness and business feasibility of providing online therapeutic information to parents of children with communication difficulties.
Secondary ID [1] 300007 0
PCHF 9813
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Speech and language developmental delay 315493 0
Condition category
Condition code
Public Health 313781 313781 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Title: Clinical effectiveness and business feasibility of providing online therapeutic information to parents of children with communication difficulties.

Background: Soon after being referred to the Metropolitan Child Development Service (CDS), most parents are invited to one or more face-to-face parent workshops. Consistent with the principles of best practice in early intervention, the Promoting Early Communication workshop provides parents with specific information and strategies, empowering them to support their child's language development in everyday natural learning environments.

Whilst these workshops are well received, consumers have reported a number of barriers to attending face-to-face sessions. The current trend towards self-managed care is being facilitated by an increase in consumer reliance on the internet for health-related information. Consistent with this broad trend, CDS consumers have also identified an interest in accessing therapeutic information online.

In addition to the barriers faced by parents, increasing numbers of referrals and limited access to suitable facilities with large group rooms are impacting on the ability to provide face-to-face sessions in a timely manner. Use of information communication technologies for health service delivery presents an opportunity to meet consumer preferences, and to improve service accessibility in the face of increasing costs and demands.

Objective: The aim of this research is to implement and evaluate an online education package (Intervention B), and compare the parent related clinical outcomes; engagement; and costs associated with the equivalent face-to-face workshop (Intervention A).

Eligible parents are randomly allocated to the face-to-face workshop (Intervention A) or the online educational package (Intervention B).

Intervention A
The Promoting Early Communication parent information workshop is a manualised, two hour face-to-face workshop for parents of children between 12 months and 36 months with communication difficulties. The workshop caters for a maximum of 15 parents at a time and is available at CDS centres across the metropolitan region.

The broad aim of the workshop is to improve parent knowledge and skills as well as their beliefs about their capability to carry out tasks at home related to parenting a child with communication difficulties, and promoting communication development.

The workshop reflects a family-centred approach and aims to build parent capacity to support their child’s communication development within everyday natural learning environments. Parents identify individual goals, and elements of coaching are used to support parents to identify strategies they can use to meet these goals. Adult learning principles have been considered in the format of the workshop with opportunities for participants to interact and learn through reading; through listening; through discussing; through observing videos and demonstrations; through reflecting on observed interactions and their own actions; and through practising strategies. Participants are provided with a handout titled 'Helping your child communicate'. The handout was developed by the Child Development Service for use in conjunction with the Promoting Early Communication workshop presentation.

The face-to face workshop (Intervention A) is presented by two experienced CDS Speech Pathologists; a primary and a supporting facilitator. Both facilitators are eligible for certified practising Speech Pathologist status with Speech Pathology Australia.
In line with the Promoting Early Communication face-to-face workshop manual, the primary facilitator is responsible for facilitating the workshop and facilitating discussion with parents, while the second facilitator supports the facilitation (i.e. scribing, data recording, supporting group work).

The primary and all supporting facilitators have suitable knowledge and experience in key areas of the workshop including:
* Several years of experience in early language facilitation
* Well-developed knowledge of working in partnership with and building the capacity of parents
* Knowledge of attachment theory and the Circle of Security model
* Knowledge of and experience in presenting workshops to parents, and in using a variety of adult learning principles and coaching methods.

Intervention B
The online education package (Intervention B) was developed with the same underlying objectives; desired outcomes and adult learning principles that were considered in the development and pilot of the face-to-face workshop.

The core content is consistent with the face-to-face workshop. Parents identify individual goals and elements of coaching are used to support parents to identify strategies to use to meet these goals. Adult learning principles were considered in the format of the online package with opportunities for participants to learn through reading; through listening; through hearing discussions; through observing videos and demonstrations; through reflecting on observed interactions and their own actions; and through practising strategies.
The 'Helping your child communicate' handout will be available for participants to access electronically through the online education package, or participants were also given the option of having a hard copy posted to them in the mail.

The online education package is an Articulate package that is housed on a Moodle based Learning Management System (LMS). The total time to complete the online education package (Intervention B) if working through it from start to finish is 2 hours, however, individual participants may choose to take longer to complete modules and may come and go from the online education package over a number of hours/days. The LMS allows for gathering of parent engagement data, including commencement and completion dates for each module and the number of times the module is accessed.

Fidelity:
Intervention A (face-to-face workshop) will be presented by the same primary facilitator in order to ensure fidelity to the manual. Compliance to the manual and objectives of the workshop will be monitored, with the supporting facilitator of a set number of workshops completing a fidelity checklist against the key points to be included in discussion against each slide, as documented in the facilitator manual.
Intervention A - participants will be asked to complete de-identified fidelity checks throughout the workshop to ensure that the information provided addressed the objectives of the workshop.

For Intervention B (the online education package), the fidelity to the face-to-face workshop will be established during development and as with Intervention A, participants will be asked to complete a fidelity checks throughout the online education package (Intervention B).
Intervention code [1] 316274 0
Treatment: Other
Comparator / control treatment
The project will adopt a non-inferiority randomised trial to determine whether an online education package (Intervention B) produces clinical outcomes that are not inferior to those achieved through the face-to-face workshop (Intervention A) (comparator/control).
Control group
Active

Outcomes
Primary outcome [1] 322241 0
Parent report of identification of actions in relation to parenting a child with communication difficulty, as assessed by 10 point Likert scale.
Timepoint [1] 322241 0
Participants will complete the post intervention outcome survey immediately after completing Intervention A or Intervention B.
Secondary outcome [1] 377838 0
Secondary question: When compared with the costs of providing face-to-face group workshop (Intervention A), is the provision of the online education package (Intervention B) a cost effective service delivery option for CDS?

A cost-consequence analysis will be adopted to answer the secondary research question of business feasibility, assuming the data indicates clinical equivalence.
Timepoint [1] 377838 0
The cost-consequence analysis will be completed once all participants have concluded their involvement in the research study (i.e. required sample size have completed the intervention and follow-up outcomes survey).
Secondary outcome [2] 377839 0
Is parent engagement with the online education package (Intervention B) comparable with engagement with the face-to-face group workshop (Intervention A).

A direct comparison between attendance (Intervention A) and completion of the entire online package (Intervention B) will be made.
Timepoint [2] 377839 0
Participant attendance rates at the face-to-face workshops (Intervention A) will be recorded manually by facilitators who will mark off participants as they arrived on an attendance register. Participant commencement and completion of each module in the online education package (Intervention B) will be monitored using the LMS analytics.

Eligibility
Key inclusion criteria
Parents:
* Parents of children aged between 12 months and 36 months with communication difficulties who have been referred to CDS and as a result of their business as usual service planning appointment, have been offered and agreed to participate in the Promoting Early Communication workshop (in line with usual collaborative discussions about services required) during the study period.
* Participants must have the required technical resources available at home (i.e. a computer or device with internet access).
* Participant (i.e. parent) is willing and able to give informed consent for themselves to participate in the study.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Parents that do not meet the inclusion criteria will be excluded from the study. The following additional exclusion criteria will also apply:
* Parents (i.e. potential participants) who are under 18 years old (as there will not be an opportunity to assess whether an individual is a mature minor capable or giving or refusing consent).
* Parents highly dependent on medical care who may be unable to give consent.
* People in other countries (in line with Eligibility and Access to Services – Child Development Service Policy, these families would not proceed to a service planning appointment, and would naturally be excluded from the study)
* Families who require an interpreter are offered a comparable one-to-one face-to-face session due to difficulties associated with delivering an effective group service through an interpreter. They are therefore excluded from the face-to-face workshops and as a result, from the research study.

Parents unwilling to participate in the study, or that do not meet the inclusion criteria, will be offered the business as usual Promoting Early Communication face-to-face workshop (not related to the study) or other appropriate CDS service.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to an intervention group using a block randomisation allocation sequence generated using Microsoft Excel. Block randomisation has been chosen to ensure each participant has equal probability of being allocated to the face-to-face workshop (Intervention A) or the online education package (Intervention B) and to maintain even allocation (numbers) to each intervention group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on the administration of the outcomes survey with the (business as usual) face-to-face workshop participants prior to the research commencing, the following details apply: Based on a mean of 8.88 (SD=1.47) for the face-to-face workshop and a margin of non-inferiority of 1, power of 90% and one sided alpha set at 0.025, a sample size of 47 per group is required. To account for a 30% loss to follow-up, a total sample size of 62 per group is required. However, due to full recruitment not having to be completed prior to commencement of intervention, recruitment will continue until a minimum of 47 per group have completed the intervention and follow up outcomes survey

Non-inferiority determination will be based on results recorded against the survey item ‘I have identified specific actions that I can do to at home to help my child’s communication development’.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
21/06/2019
Date of last participant enrolment
Anticipated
Actual
19/12/2019
Date of last data collection
Anticipated
Actual
12/02/2020
Sample size
Target
124
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 304459 0
Charities/Societies/Foundations
Name [1] 304459 0
Perth Children's Hospital Foundation
Country [1] 304459 0
Australia
Funding source category [2] 304739 0
Government body
Name [2] 304739 0
Child and Adolescent Health Service - Community Health
Country [2] 304739 0
Australia
Funding source category [3] 304740 0
Government body
Name [3] 304740 0
Child and Adolescent Health Service - Executive (Human Research Ethics Committee and Research Governance Office)
Country [3] 304740 0
Australia
Primary sponsor type
Government body
Name
Child and Adolescent Health Service - Community Health
Address
PO Box S1296, Perth WA 6845
Country
Australia
Secondary sponsor category [1] 304728 0
None
Name [1] 304728 0
Address [1] 304728 0
Country [1] 304728 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304893 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 304893 0
Ethics committee country [1] 304893 0
Australia
Date submitted for ethics approval [1] 304893 0
18/02/2019
Approval date [1] 304893 0
21/03/2019
Ethics approval number [1] 304893 0
RGS0000001201

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98554 0
Dr Chris Lewis
Address 98554 0
Child and Adolescent Health Service - Community Health, Child Development Service
PO Box S1296, Perth WA 6845
Country 98554 0
Australia
Phone 98554 0
+61 8 9323 6666
Fax 98554 0
Email 98554 0
[email protected]
Contact person for public queries
Name 98555 0
Deborah Flynn (Director Clinical Services, Child Development
Address 98555 0
Child and Adolescent Health Service - Community Health, Child Development Service
PO Box S1296, Perth WA 6845
Country 98555 0
Australia
Phone 98555 0
+61 8 9323 6666
Fax 98555 0
Email 98555 0
[email protected]
Contact person for scientific queries
Name 98556 0
Chris Lewis
Address 98556 0
Child and Adolescent Health Service - Community Health, Child Development Service
PO Box S1296, Perth WA 6845
Country 98556 0
Australia
Phone 98556 0
+61 8 9323 6666
Fax 98556 0
Email 98556 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently no plan for data sharing.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.